Veterinary Medicines

RISPOVAL 2

Authorised
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • ALUMINIUM HYDROXIDE GEL
  • Bovine respiratory syncytial virus, strain 375, Live
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Product identification

Medicine name:
RISPOVAL 2
Rispoval 2 / BRSV + Pi3 Lyofilisaat en oplosmiddel voor suspensie voor injectie voor runderen
Active substance:
  • Bovine parainfluenza virus 3, strain RLB103, Live
  • ALUMINIUM HYDROXIDE GEL
  • Bovine respiratory syncytial virus, strain 375, Live
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Bovine parainfluenza virus 3, strain RLB103, Live
    100000.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Dose
  • ALUMINIUM HYDROXIDE GEL
    1.00
    unit(s)
    /
    1.00
    Dose
  • Bovine respiratory syncytial virus, strain 375, Live
    100000.00
    log10 50% tissue culture infectious dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • Cardboard box with 1 vial of lyophilisate (5 doses) and 1 vial of solvent (20 ml)
  • Cardboard box with 1 vial of lyophilisate (25 doses) and 1 vial of solvent (100 ml)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 125373
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0420/001
Concerned member states:
  • Belgium
  • Croatia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Ireland
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 3/09/2024
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